Proven Economic and
Social Benefits from Switch
Nicotine Replacement Therapy
Ian AdamsVice-President, Regulatory & Quality
Asia-Pacific and Latin America
GSK Consumer Healthcare
WSMI Phuket, October 2014
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GlaxoSmithKline Consumer Healthcare A leader in the worldwide consumer healthcare market.
Underpinned by our Science and our Values
Four Global Categories
−Wellness, Oral Healthcare, Nutritionals, Skincare
Many Global Brands
− eg Panadol, Aquafresh, Sensodyne, Poligrip, Lucozade, Horlicks & NiQuitin
Over £4 billion in yearly sales
A presence in >130 worldwide markets.
Announced a potential Joint Venture with Novartis Consumer Healthcare
We are dedicated to improving the quality of human life by enabling
people to do more, feel better and live longer
Economic and Social Benefits of Switch
Increase consumer access to treatments proven to be safe and
effective
Increase consumer empowerment and knowledge (Self care)
Build engagement between consumers and healthcare
professionals
Reduce healthcare system costs
“ People want to have a more active role in their own healthcare,
including the decisions about what medicines to take. When it comes
to access to self-medication, good information and support translate
into empowered patients who can benefit fully from the opportunities of
self-care and who can practise it safely and effectively with informed
choice.”
Report of the EU Working Group on promoting good governance of non-prescription
drugs in Europe, June 2013
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Economic and Social Benefits of Switch (2)
What would happen if current OTC Categories were no longer
available?
− Increase of US $102bn in direct and indirect costs in the US
across 7 categories (Booz Allen 2013)
− Increase of >AUS $10bn in direct and indirect costs in Aus across
8 categories, including smoking cessation (Macquarie University
2014)
−Similar studies carried out in France, UK, Spain, Netherlands,
Italy in recent years
.
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Global Distribution of Smokers
The burden of smoking related disease
Tobacco use is the leading preventable cause of death globally, killing
up to one half of the people who use it.
If current global trends continue, it is estimated that tobacco will kill
more than 8 million people annually by 2030 (approx 75% in low and
middle-income countries).
One third of the world's smokers reside in the WHO Western Pacific
Region, where it is estimated that two people die every minute from a
tobacco-related disease.
Approximately 125 million or 30% of all adults in South East Asia are
current smokers with tobacco consumption increasing and
one of the highest rates of male smoking prevalence,
high prevalence in some ethnic groups, low socio-economic groups and rural
populations,
the fastest increase of tobacco use uptake by women and young people, and
increasing second-hand smoke issue for children. 6
A Global Epidemic
Percentage of deaths from tobacco use
0
5
10
15
20
25
30
U.S., Canada France, Italy, Turkey,U.K.
Japan Indonesia India Brazil, Argentina,China
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World Health Organization. Tobacco Atlas. World Health Organization Tobacco Free Initiative. 2010. Derived from:
Ezzati M, Lopez AD. Estimates of global mortality attributable to smoking in 2000. Lancet 2003; 362: 847-852
A Global Epidemic
Burden of disease from tobacco use
8
90%
75%
25%
0 10 20 30 40 50 60 70 80 90 100
Lung Cancer
Chronic Bronchitis & Emphysema
Ischaemic Heart Disease
Percent of Disease Caused By Smoking
World Health Organization. Tobacco Atlas. World Health Organization Tobacco Free Initiative. 2002
Health Consequences of Smoking
and Quitting
Quitting smoking reverses health risk
−Some quickly (e.g., sudden cardiac death)
−Some slowly (e.g., cancer)
−Stops progression (e.g., emphysema)
But it isn’t easy….
−40% of smokers resume smoking after an MI
−1/3 of cessation efforts do not last 2 days
−Many smokers need >5 attempts to quit
−Most smokers experience nicotine withdrawal
WHO Action Plan/Global Strategy (2008-13)
Prevention and Control of Non-Communicable Diseases
“Today, non-communicable diseases (NCDs), mainly cardiovascular diseases, cancers, diabetes and chronic respiratory diseases, represent a leading threat to human health and development.
These four diseases are the world’s biggest killers, causing an estimated 35 million deaths each year – 60% of all deaths globally – with 80% in low- and middle-income countries.
“These diseases are preventable. Up to 80% of heart disease, stroke and type-2 diabetes and over a third of cancers could be prevented by eliminating shared risk factors, mainly tobacco use, unhealthy diet, physical inactivity and the harmful use of alcohol.”
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Initiatives to Reduce Smoking Prevalence
Prohibition of Advertising, Promotion & Sponsorship
Increased
Tobacco Tax
Regulation of Products
Tobacco Control Prohibition of
Smoking in
Public
Places
Regulation of
Place of Sale
Sales to and by Minors
Smoking Control Cessation
Services &
Treatment**
Warn about the dangers of Tobacco
Promotion of Quit & Smoke-free messages
Smoking Cessation
**Increase availability, accessibility and affordability of NRT and
other effective pharmaceutical interventionsWHO REGIONAL ACTION PLAN FOR THE TOBACCO FREE INITIATIVE
IN THE WESTERN PACIFIC (2010–2014)
History of Nicotine Replacement Therapy
First US Rx Launch in 1984 (2mg Gum) followed by Patch in
1992
First OTC launch in 1996 (Gum & Patch)
Available in >130 countries
Proven efficacy and safety of NRT when used as directed.
Hundreds of clinical trials involving more than 35,000 participants
Extensive consumer use for more than 20 years have
NRT products have helped millions of smokers quit by gradually
weaning them off of their tobacco addiction and is
recommended as a first-line therapy for quitting.
2Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database of
Systematic Reviews 2008, Issue 1.
Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville,
MD: U.S. Department of Health and Human Services. Public Health Service. May 2008.12
Trends in Use
13CDC. Use of FDA-approved pharmacologic treatments for tobacco dependence – United States, 1984-1998. MMWR 2000;49(29):665-668.
Benefits of US NRT Switch
Markedly increased access post switch
78-92% increase in patch use
180% increase in gum use
Number of Quit attempts was estimated to double
2.5 m in 1995 ( before switch)
5.7 m in 1997 ( after switch)
Sustained Utilisation due to ongoing communications
Net annual social benefits of USD $ 1.8-2bn
Keeler et al, (2002) Health Economics; 11(5) 389-402
Shiffman & Sweeney (2008) Health Policy; 86, 17-2614
Shi
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United Kingdom Widening Access to Self-Care
Public Health Benefits of Switch
UK Regulatory or Policy Change Date
Nicotine gum (2 mg) available general sale (GSL) March 1999
Introduction of treatment for smokers
throughout England free through the NHS
April 2000
Bupropion available on NHS prescription June 2000
All smoking cessation products available on
NHS prescription
April 2001
Nicotine gum (4 mg), nicotine lozenge, and all
nicotine patches available for GSL
May 2001
Successful National Public Health Policies
Increased NRT access and broader UK Initiatives
Cigarette tax increases
Clean indoor air laws
Advertising restrictions
Product labeling
Mass media policies
School education programs
Youth access enforcement
Access to cessation treatments
Telephone quit lines
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Levy DT, Chaloupka F, Gitchell JG. The effects of tobacco control policies on smoking rates: a tobacco control scorecard. J
Public Health Management Practice 2004;10(4):338-353.
World Health Organization. WHO Report on the Global Tobacco Epidemic, 2011. World Health Organization. 2011
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Public Health Outcomes - Trends in UK Smoking
0
10
20
30
40
50
60
%
Men
Women
UK Office of National Statistics, 2011 – UK Adult smoking trends
NRT GSL Switches
Progress of UK Initiatives
Dramatic increase in sales of medications to aid smoking cessation
Widening general sales access was associated with increase in sales
Significant effects of making bupropion and NRT reimbursable
Making NRT reimbursable on NHS prescription increased prescription sales without evidence of decline in OTC use
Significant increase in total sales following launch of new NRT formats (eg, lozenge )
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West R, DiMarino ME, Gitchell J, McNeill A. The impact of UK policy initiatives on use of medicines to aid
smoking cessation. Tobacco Control 2005 Jun;14(3):166-71.
Increased Utilization in Australia
Moving NRT from BTC to OTC
50%
100%
150%
200%
250%
% o
f B
TC
(B
TC
=100%
)
BTC/Pharmacy
OTC/Pharmacy
OTC/Wider trade
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Source: GSK Australia, 2002-2007
Increased Utilization in AustraliaMoving NRT from BTC to OTC
Smoking prevalence has continued to fall in Australia
as a result of a range of complementary and
innovative initiatives; eg
−Graphic pictures and plain cigarette packaging
Estimated > 68,000 successful quitters and premature
deaths have been prevented in the ten years since
NRT switch in Australia
Bittoun (2007) A Decade of NRT. Smoking Cessation Research Unit, University of Sydney
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Effective Use of NRT
21
0 2 4 6 8 10 12 14
Tailored online support
One-to-one support
Group support
Telephone support
NRT alone
NRT/bupropion + support
Treatment-related increase in successful quitting (%)
West R, Shiffman, S. Fast Facts: Smoking Cessation. 2007. Health Press.. Oxford, UK
Effective Use of NRT
Smokers harbor misperceptions about the safety of NRT because it
contains nicotine; however, using NRT products to quit smoking is far
safer than continuing to smoke.
Smokers need to be educated about NRT and the role it can play in
helping to reduce and eliminate a smoker’s dependence on nicotine
from cigarettes.
There is evidence to suggest that providing accurate efficacy and
safety information can increase a smoker’s willingness to use NRT as
part of a quit attempt.
Hughes JR, Keely J, Naud S. (2004) Addiction, 99, 29-38.
Survey of 900 adult smokers in the U.S. conducted by American Legacy Foundation and GSK Consumer Healthcare (Aug 2007)
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OTC Switch of NRT – For & Against
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Thank You
We are dedicated to improving the quality of human life by enabling
people to do more, feel better and live longer
www.gsk.com
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